their premier drug candidate, IDX184, were put on partial clinical hold by the FDA. The government organization’s decision was based on a recent report of a serious cardiac-related adverse event associated with Bristol-Myers Squibb’s drug, BMS-986094. Both drugs are nucleotide polymerase inhibitors being developed to treat Hepatitis C (HCV) infections.
Idenix’s IDX184, developed as an orally administered once-a-day therapy, has been tested in combination with other HCV-prescribed treatments such as pegylated interferon and ribavirin. This is not the first time that the company’s leading candidate has been benched due to concerns with the safety and toxicity profile associated with its nucleotide inhibitor related therapy. A partial clinical hold was placed on IDX184 as recently as 2010, due to elevated liver function tests performed on the treatment population. This partial hold was only lifted in February of 2012 after concerns were addressed by company officials.
Idenix’s shares plummeted almost 30%, to $5.90, after release of the company statement. Certain investors have predicted that this setback will tack on an additional six months to Idenix’s development schedule, but that the company will still be able to deliver on their promise of an HCV cure. It is likely that this setback has done more to damage the momentum of IDX184 than analysts predict. For now, Idenix has stated that they plan to perform cardiac assessments on all patients that have undergone clinical trials with IDX184, in an effort to comply with guidelines set out by the FDA since the events associated with BMS-986094.
As reported earlier, Idenix recently received a fast-track designation for its second candidate, IDX719, which is an NS5A inhibitor capable of providing treatment against multiple genotypes of HCV. Unlike IDX719, IDX184 is directed towards genotype 1 HCV and uses a different Mechanism Of Action (MOA). The adverse events associated with the combinatorial agents have been a driving force for technological innovation in this disease space. Due to the difference in MOAs, it is possible that IDX719 might overtake IDX814 as the company’s leading drug candidate. In this regulated environment, it is possible that a change in corporate strategy might impact the guidelines used to determine the fate of other nucleotide inhibitor drugs.
Currently, the competition for HCV drug development is fierce. Big players such as Bristol-Myers Squibb, Gilead and Abbott stand as stiff competition for Idenix, which can’t compete with these giants on sheer magnitude alone. These companies also benefit from diversified portfolios, - a luxury that a smaller biotech company like Idenix lacks. This might have implications on the company’s ability to weather development delays.
The status of HCV treatment leaves a lot to be desired. Currently, estimates indicate that approximately 3% of the world’s population is infected with HCV. Infected individuals often go on to suffer from exacerbated conditions such as liver cirrhosis and even liver cancer. In this market, treatments such as Idenix’s IDX184 and IDX719 stand out as strong contenders capable of changing the landscape of treatment algorithms on a global scale. With a strong push from global health avenues such as the one from the CDC recommending HCV testing in all baby boomers, one can expect Idenix to rally back and emerge as a real contender in HCV treatment. However, it remains to be seen if this can be achieved with IDX184 instead of its worthy replacement, IDC719.
One Bad Apple? Idenix Pharmaceuticals’ IDX184 Takes the Heat for Competitor’s Toxicity Profile
This expert insight was written by GlobalData's senior healthcare analyst for infectious diseases, Dr. Ramya Kartikeyan. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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